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Managing Research Involving Human Subjects: What, Me Worry?

Managing Research Involving Human Subjects: What, Me Worry?

On Tuesday, January 24th Michele Russell-Einhorn, JD, Senior Director, Office of Human Studies at the Dana-Farber Institute will join us at MCW to present “Managing Research Involving Human Subjects: What, Me Worry?”  Ms. Russell-Einhorn will acquaint the audience with the greatest ethical and regulatory priorities when managing human subjects research, review the role of the Principal Investigator vis-à-vis the study team member in clinical research, and discuss ways to approach the informed consent process and to manage unanticipated problems.

This presentation is co-sponsored by the MCW Office of Research and Regulatory Knowledge and Research Ethics key function of CTSI. Everyone interested in human research is welcome. Programs are typically structured with MCW specific information.

CME Credit: 1.0 credit.
Date: Tuesday, January 24, 2012
Place: Kerrigan Auditorium
11:30am Open for Seating and Announcements; 12:00pm to 1:00pm Presentation

Lunch will be provided. Registration is required.
For program questions or special needs, contact Toby Welch.

About the presenter

Michele Russell-Einhorn

Michele K. Russell-Einhorn is the senior director of the Office for Human Research Studies at the Dana-Farber Cancer Institute and is responsible for scientific review and institutional review board review, as well as other regulatory matters, involving all cancer research involving human subjects conducted at the five Harvard clinical institutions under the umbrella of the Dana-Farber/Harvard Cancer Center.

Trained as a lawyer, she has over 26 years of professional experience including service as the conflicts of interest attorney for the National Institutes of Health; director of regulatory affairs for the U.S.D.H.H.S. Office for the Protection from Research Risks and its successor office, the Office for Human Research Subjects; Director in the Global Pharmaceuticals Practice at PWC; as well as the associate general counsel for the J. Craig Venter Institute.

NIH Funding Acknowledgment: Important Reminder – Please acknowledge the NIH when publishing papers, patents, projects, and presentations resulting from the use of CTSI resources by including the NIH Funding Acknowledgement.


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